MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.55MM X 10MM TWIST DR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	S-1510TD-G1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Event or Problem Description
It was reported that the patient underwent an unknown surgery for pneumocephalus on head where the cutting burs were used.In the surgery, during a craniotomy, three of the cutting burrs broke in succession.The breakage occurred while they were being used on a patient's bone fragment that had been removed during the craniotomy.The operation was extended by approximately 10 minutes, but the fourth new twist drill cutting burr was opened and used before the operation was completed.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.Report 2 of 3 (b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h4.Device manufacture date: added accordingly.Corrected data: d4.Primary udi number.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: review of the device history record(s) showed that there are no relevant issues during the manufacture of this product which would contribute to this complaint condition.

• Brand Name: 1.55MM X 10MM TWIST DR,S
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: elba bello ; 4500 riverside drive; palm beach gardens, FL 33410 ; 9083863534
• MDR Report Key: 23883372
• Report Number: 1045834-2025-00659
• Device Sequence Number: 15865764
• Product Code: HBE
• UDI-Device Identifier: 00845384012610
• UDI-Public: (01)00845384012610(10)V303160251
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: S-1510TD-G1
• Device Lot Number: V303160251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/04/2026; 03/19/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/04/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown